Status:
UNKNOWN
Effect of Renal Denervation on Stress, Hypertension and Anxiety Management
Lead Sponsor:
Hippocration General Hospital
Collaborating Sponsors:
ReCor Medical, Inc.
Conditions:
Hypertension Arterial
Anxiety
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
Brief Summary
The ERSHAM (Effect of Renal Denervation on Stress, Hypertension and Anxiety Management) is a single-center, interventional, open-label, randomized controlled trial that will be conducted at the Hypert...
Detailed Description
Background Uncontrolled hypertension (HTN) is of multifactorial origin and continues to represent a major public health issue. Sympathetic renal denervation (RDN) has been proposed as a promising, mi...
Eligibility Criteria
Inclusion
- Consecutive patients aged 30-70 years with arterial hypertension diagnosed at least 3 months prior to the inclusion.
- Office blood pressure (OBP) \>140/90mmHg and \<160/100 mmHg
- Either no baseline hypertension treatment or hypertension treatment with one drug. The antihypertensive treatment will include a renin-angiotensin system (RAS) blocker \[either an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB)\] or a calcium channel blocker (CCB).
- Unchanged antihypertensive therapy during the prior 8 weeks.
- Patients with baseline anxiety subscore ≥ 8 according to the Hospital Anxiety and Depression Scale (HADS)
Exclusion
- Patients with secondary arterial hypertension or under treatment with b-blockers, diuretics, mineralocorticoid receptors antagonists (MRAs) or a centrally acting alpha-adrenergic agonist.
- Patients under treatment with antidepressants and/or anxiolytic drugs.
- Patients with a glomerular filtration rate (eGFR)\] \<45 ml / min / 1.73 m2 calculated using the CKD-EPI formula15.
- Patients with evidence of any of the following criteria on either renal artery side:
- Main renal artery diameter \< 3.0 mm or \> 8 mm
- Main renal treatable artery length \< 20 mm
- Presence of renal artery stenosis of any origin ≥ 30%
- Accessory arteries with diameter ≥ 2mm \<3.0 mm
- Calcification in renal arteries at location where energy is to be delivered
- A single functioning kidney
- Prior renal denervation procedure
- Presence of abnormal kidney tumors
- Renal artery with aneurysm
- Pre-existing renal stent or history of renal artery angioplasty
- Pre-existing aortic stent or history of aortic aneurysm
- Fibromuscular disease of the renal arteries
- Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
- Patients with a history of acute coronary syndrome or stroke during the previous six months or Scheduled coronary interventional therapy during the next six months.
- Patients with permanent atrial fibrillation, chronic heart failure and NYHA functional status II-IV, Cancer under therapy (radiotherapy, chemotherapy, immunotherapy)
- Patients with life expectancy \<1 year (at the time of inclusion).
- Pregnant women or women who are planning to become pregnant.
- Patients who do not provide written consent to participate in the study
Key Trial Info
Start Date :
October 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05438446
Start Date
October 18 2021
End Date
December 1 2023
Last Update
July 7 2022
Active Locations (1)
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1
Hippokration Hospital of Athens
Athens, Attica, Greece, 11527